Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We have made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom
right of each page!
|
e-CFR data is current as of April 19, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1300 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1300 Follicle-stimulating hormone test system.
(a) Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]